The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to the widely used and marketed r-hFSH Gonal-f.

Local and systemic adverse events [ Time Frame: Systemic adverse events: Screening visit until approx. 40 weeks after the confirmation of biochemical pregnancy. Local adverse events: up to a max. of 16 days after the start of the FSH treatment ] [ Designated as safety issue: Yes ]

Evaluation of possible local adverse events due to subcutaneous injections, such as erythema, hematoma, induration etc. using a patient diary. Assessment of systemic adverse events incl. ovarian hyperstimulation syndrome (OHSS) by physical examination and laboratory assessments.

Pregnancy outcome [ Time Frame: Follow-up period starting the time of confirmation of clinical pregnancy until 40 weeks after confirmation of biochemical pregnancy (birth) ] [ Designated as safety issue: Yes ]

Follow-up of ongoing pregnancy from date of confirmation of clinical pregnancy until birth including neonatal phase of 28 days

One subcutaneous injection of 225IU Gonal-f (follitropin-alfa) per day (initial dose) for the first 6 days. Increase of dose to a maximum of 450IU per day after initial dosing period if deemed necessary

Drug: Gonal-f

225IU subcutaneously, starting at the day of successful down-regulation for the first 6 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached

Other Name: Follitropin-alfa

Experimental: AFOLIA

One subcutaneous injection of 225IU AFOLIA (follitropin-alfa) per day (initial dose) for the first 6 days. Increase of dose to a maximum of 450IU per day after initial dosing period if deemed necessary

Drug: AFOLIA

225IU subcutaneously, starting at the day of successful down-regulation for the first 6 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached

Other Name: Follitropin-alfa

Detailed Description:

Comparison of the clinical pregnancy rate in the AFOLIA group compared to the Gonal-f group as the primary endpoint. Comparison of the number and size of follicles, the number of cycle cancellation, the hormone parameters and adverse events in the AFOLIA group compared to the Gonal-f group as secondary endpoints.

History of a maximum of two fresh cycle treatments in the present series of assisted reproductive technologies (ART) at the day of first screening (thawed cycles are not subject to that criteria)

Body mass index (BMI) ≥18 and ≤38 kg/m2

Basal FSH <12 IU/L (cycle day 2-5)

Antral follicle count (AFC) ≥ 10 to ≤20 follicles with a diameter of <11mm (sum of both ovaries) as measured on ultrasound (US) in the early follicular phase (menstrual cycle day 2-5)

Documented history of infertility due to any of the following factors: tubal factor, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1-2), male factor, unexplained infertility

Presence of both ovaries by ultrasonography and normal uterine cavity (confirmed by hysterosalpingography, saline infusion sonography or hysteroscopy within 6 months before randomization)

Male partner with semen analysis that is at least adequate for ICSI within 6 months prior to patient beginning down-regulation (invasive or surgical sperm retrieval, donor and/or cryopreserved sperm may be used)

Willingness to participate in the study and to comply with the study protocol

Signed informed consent prior to screening

Exclusion Criteria:

Presence of pregnancy

History of or active polycystic ovary syndrome (PCOS)

AFC >20 follicles with a diameter of <11 mm (both ovaries combined) as measured on US in the early follicular phase (menstrual cycle day 2-5)

Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medications (GnRH agonist, Ovidrel®, and Crinone 8%®)

History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)

Any hormonal treatment within 1 month before the start of the FSH treatment, with the exception of levothyroxine)

Egg donor

Administration of other investigational products within the previous month

Clinically abnormal findings at Visit 1

Concomitant participation in another study protocol

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687712